Nonunion of FractureNCT03937310
NGS for Non-unions
An observational study of Nonunion of Fracture, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of this study is to investigate the role of genetic testing to look for possible infection as a cause for failure of non-healing fractures. The study aims to compare the results of genetic testing known as NGS to standardized clinical laboratory tests for diagnosing infections to see if NGS may be a better… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonunion of Fracture
- What is being tested?
- Next-generation sequencing of swabs collected during surgery
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 3 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients will be chosen based on intervention planned. This is not an interventional study, just an observational study
Who may be able to join
- Patients undergoing open biopsy / surgical intervention for nonunion following a traumatic (open or closed) long bone fracture (femur shaft, tibia, humerus) which was initially treated operatively.Inclusion Criteria:
- Nonunions will be defined as a failure to progress towards expected union within an anticipated timeframe, and this judgment will be made by the attending caring for each patient. No specific timeframe or arbitrary cut points will be defined to allow for the considerable variation in fracture healing and different anatomical sites.
- Presumed Septic and Aseptic nonunions
- >18 years old and able to provide informed consent
- Patients undergoing surgical intervention for nonunion following a traumatic closed long bone fractures (femur shaft, tibia, humerus)
- >18 years old and able to provide informed consent
Who cannot join
- Pathological fractures at index injury
- Patients on antibiotic therapy <2 weeks prior to surgery
- Pathological fractures at index injury
- Patients on antibiotic therapy <2 weeks prior to surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What is the Role of Next-generation Sequencing in Non-union of Orthopaedic Cases
The purpose of this study is to investigate the role of genetic testing to look for possible infection as a cause for failure of non-healing fractures. The study aims to compare the results of genetic testing known as NGS to standardized clinical laboratory tests for diagnosing infections to see if NGS may be a better diagnostic tool.
- Conditions
- Nonunion of Fracture
- Being tested
- Next-generation sequencing of swabs collected during surgery
- Medical subject headings
- Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next-generation sequencing of swabs collected during surgeryDiagnostic test
Traditional swabs for culturing as well as swabs for NGS testing will be collected
| Study group | Role | What they receive |
|---|---|---|
| Surgical intervention for non-union | The investigation group will consist of cases undergoing surgical intervention for non-union Receives: Diagnostic Test: Next-generation sequencing of swabs collected during surgery | |
| Acute fracture fixation | The control group will consist of cases undergoing acute fracture fixation Receives: Diagnostic Test: Next-generation sequencing of swabs collected during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Need for additional re-operation or intervention within follow-up period
Measured: 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start3 Jan 2019
- Primary completion3 Jan 2022 (estimated)
- Study completion3 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonunion of FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937310
- Sponsor's protocol ID
- Krieg2019
- Status last verified
- May 2019
- First submitted
- 1 May 2019
- Last updated
- 3 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Role of Next-generation Sequencing in Non-union of Orthopaedic Cases
- ClinicalTrials.gov ID
- NCT03937310
- Acronym / sponsor ID
- Krieg2019
- Conditions
- Nonunion of Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 3 Jan 2022 (estimated)
- Study completion
- 3 Feb 2022 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the role of genetic testing to look for possible infection as a cause for failure of non-healing fractures. The study aims to compare the results of genetic testing known as NGS to standardized clinical laboratory tests for diagnosing infections to see if NGS may be a better diagnostic tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical intervention for non-union | – | Diagnostic Test: Next-generation sequencing of swabs collected during surgeryThe investigation group will consist of cases undergoing surgical intervention for non-union |
| Acute fracture fixation | – | Diagnostic Test: Next-generation sequencing of swabs collected during surgeryThe control group will consist of cases undergoing acute fracture fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients will be chosen based on intervention planned. This is not an interventional study, just an observational study
Key inclusion criteria (6 listed)
- Patients undergoing open biopsy / surgical intervention for nonunion following a traumatic (open or closed) long bone fracture (femur shaft, tibia, humerus) which was initially treated operatively.Inclusion Criteria:
- Nonunions will be defined as a failure to progress towards expected union within an anticipated timeframe, and this judgment will be made by the attending caring for each patient. No specific timeframe or arbitrary cut points will be defined to allow for the considerable variation in fracture healing and different anatomical sites.
- Presumed Septic and Aseptic nonunions
- >18 years old and able to provide informed consent
- Patients undergoing surgical intervention for nonunion following a traumatic closed long bone fractures (femur shaft, tibia, humerus)
Key exclusion criteria (4 listed)
- Pathological fractures at index injury
- Patients on antibiotic therapy <2 weeks prior to surgery
- Pathological fractures at index injury
- Patients on antibiotic therapy <2 weeks prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next-generation sequencing of swabs collected during surgeryTraditional swabs for culturing as well as swabs for NGS testing will be collected | Diagnostic test | Acute fracture fixation, Surgical intervention for non-union |
Primary outcome
Treatment failure
Time frame: 6 months post-op
Need for additional re-operation or intervention within follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonunion of Fracture, run by Rothman Institute Orthopaedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 6 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.